Integration of control software with a medical device and system

ABSTRACT

A medical device for diagnosis or treatment of tissue is disclosed. The device includes an electronically-controlled tool configured for diagnosis or treatment, an electrical connector, and a computer readable memory. The electrical connector is configured for connection with an electronic control unit and configured to receive control signals, including signals concerning the operation of the tool, from the electronic control unit. The computer readable memory is accessible through the connector. The memory can include a set of programming instructions for control of the tool, and the programming instructions can be configured to be downloadable from the memory upon connection of the electrical connector with the electronic control unit. A system is also disclosed in which the electronic control unit is configured to transmit a data log from memory in the electronic control unit to the memory in the medical device upon the occurrence or detection of a predetermined event.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/990,872, filed 8 Jan. 2016 (the '872 application), now pending, whichis a continuation of U.S. application Ser. No. 14/050,570, filed 10 Oct.2013 (the '570 application), now U.S. Pat. No. 9,262,252, which is acontinuation of U.S. application Ser. No. 11/964,946, filed 27 Dec. 2007(the '946 application), now U.S. Pat. No. 8,562,600. The '872application, '570 application, and '946 application are each herebyincorporated by reference as though fully set forth herein.

BACKGROUND

The invention relates to a system and method used for the diagnosisand/or treatment of tissue. More particularly, the instant inventionrelates to a system and method involving the integration of controlsoftware with a medical device that is configured for performing thediagnosis or treatment.

Medical systems and procedures commonly involve the diagnosis andtreatment of tissue. Conventional medical systems and procedures ofteninvolve the application of energy or electrical stimulus to tissue, forexample, in surgical ablation procedures associated with endocardial andepicardial applications. An example of such a procedure is epicardialablation for creating a transmural lesion. Other systems and proceduresalso may involve various mapping, diagnosis, and/or therapeuticfunctions or treatments.

Such medical systems and procedures commonly involve both reusablecapital equipment and single-use, disposable devices. Moreover, themedical devices associated with such systems often includeelectronically-controlled tools (e.g., ablation catheters, probes,electrodes, or transducers), which may be software controlled.

Some conventional software-controlled medical systems and devicesinclude a non-volatile storage memory (e.g., EPROM) that provideidentification and/or calibration data or information to various typesof control units. However, for many applications it may be desirable toprovide a medical device or tool that can offer additional benefits) andthat, at least to some extent, can be characterized as a “smart” medicaldevice.

Additionally, when a fault is associated with conventional disposabledevices, such devices are commonly returned with just the instrument'sidentification information, such as serial numbers, type of device, orother identification “tags,” embedded therein. Engineers and technicianstypically request and obtain logs from the associated capital equipment.Such logs are typically uploaded or transferred to some form of mediaand are separately provided for analysis. It is therefore desirable fordevices and/or procedures that simplify or otherwise improve thefault-reporting process.

BRIEF SUMMARY

The invention relates to a device and system that may be employed fordiagnostic and/or therapeutic procedures m medicine, including minimallymvaslve cardiac electrophysiology studies and/or cardiac ablationprocedures. The device includes an electronically-controlled toolconfigured for diagnosis or treatment, an electrical connector, and acomputer readable memory. The electrical connector is configured forconnection with an electronic control unit and configured to receivecontrol signals, including signals concerning the operation of the tool,from the electronic control unit.

The computer readable memory is accessible through the connector. Thememory can include a set of programming instructions for control of thetool, and the programming instructions can be configured to bedownloadable from the memory upon connection of the electrical connectorwith the electronic control unit.

A system is also disclosed in which the electronic control unit isconfigured to transmit a data log from memory in the electronic controlunit to the memory in the medical device upon the occurrence ordetection of a predetermined (i.e., a select or predetermined) event.

The foregoing and other aspects, features, details, utilities andadvantages of the present invention will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graphical perspective representation of a control unit inaccordance with an embodiment of the invention.

FIG. 2 is a graphical perspective representation of a medical device inaccordance with an embodiment of the invention.

FIG. 3 is a graphical perspective representation of a medical device inaccordance with an embodiment of the invention.

FIG. 4 is a flowchart generally depicting an exemplary method ofproviding programming instructions to an electronic control unitaccording to an embodiment of the invention.

FIG. 5 is a flowchart generally depicting an exemplary method ofproviding data log information from a memory associated with a controlunit to a memory associated with a disconnectable medical deviceaccording to an embodiment of the invention.

DETAILED DESCRIPTION

Referring now to the drawings wherein like reference numerals are usedto identify identical components, FIG. 1 generally illustrates aperspective view of an electronic control unit 10 in accordance with anembodiment of the invention. FIGS. 2 and 3 generally illustrateexemplary medical devices 20, 30 that may be used in connection withvarious types of electronic control units in connection with thediagnosis and/or treatment of tissue. Together an electronic controlunit (e.g., control unit 10) and an associated medical device (e.g.,devices 20 or 30) may be combined to form a medical “system.” However,the invention is not limited to the exemplary control unit and medicaldevices illustrated, and numerous other electronic control units,medical devices, and associated systems may come within the spirit andscope of the inventive concept.

In accordance with an embodiment of the invention, an electronic controlunit, which may also be referred to as an “ECU” or an “electroniccontrol system,” includes a memory, such as an internal resident memory.The electronic control unit can be adapted or configured for connectionwith one or more medical devices, and may further be configured to,among other things, provide control signals to a connected medicaldevice. For some applications the electronic control units may provideor deliver energy, e.g., ablative energy, such as ultrasound or HIFU,and may include various user interface features and controls. An exampleof a control unit, without limitation, is the Epicor™ Ablation ControlSystem (ACS) offered by St. Jude Medical.

The medical device comprises a device for the diagnosis or treatment oftissue. In embodiments of the invention, for example as generallyillustrated in FIGS. 2 and 3, the medical device 20, 30 includes anelectronically-controlled tool 40, an electrical connector 50, and acomputer readable memory.

The electronically-controlled tool 40 may be configured for diagnosisand/or therapeutic treatment of tissue. For example, theelectronically-controlled tool may include an ablation device—e.g., anablation catheter and/or one or more ultrasound transducers, which mayinclude one or more high intensity focused ultrasound (HIFU)transducers. In an embodiment, the tool may be configured for performingcardiac ablation, such as epicardial ablation. However, the toolassociated with the system may take the form of various otherelectronically-controlled tools, and is not limited to the exemplarytools 20, 30 shown in connection with FIGS. 2 and 3. Moreover, ifdesired, for a number of applications, the medical device can comprise asingle-use or disposable medical device. Examples of medical devicesthat may be used in connection with embodiments of the inventioninclude, without limitation, The UltraCinch™ Ablation Device and TheUltraWand™ Handheld Ablation Device, both offered by St. Jude Medical.

The electrical connector 50 may be configured for connection with acompatible electronic control unit, and may further be configured toreceive control signals from the electronic control unit. The computerreadable memory associated with the medical device may be accessiblethrough the electrical connector 50, and may include a set ofprogramming instructions that, at least in part, are used to control theassociated tool. If desired, the computer readable memory may beresident within a portion of the electrical connector and/or theelectronically-controlled tool. Further, rather than just providing astatic non-volatile memory, the computer readable memory associated withembodiments of the invention may instead be configured to provide adesired level of computing capability in connection with the medicaldevice itself.

In an embodiment, the programming instructions associated with thecomputer readable memory can, among other things, comprise a transientcomputer script, code, module, or algorithm (the foregoing individuallyand collectively hereinafter simply referred to as “script”) configuredto control some aspect associated with the operation of the tool by theelectronic control unit. By way of example, the programming instructionscan be used to implement “control variations,” such as those in the formof temporary software changes. As such, the medical device, which for anumber of embodiments may be disposable, can provide data orinstructions to the electronic control unit that may beapplication-specific, so as to better optimize use or one or morefunctions associated with the behavior of the system and/or the specificmedical device or the associated tool at the point of care. For example,a medical device (e.g., an epicardial ablation device) with an improvedor upgraded membrane that does not require constant fluid flow tomitigate risk of device damage during low-frequency ablation might alterthe ECU programming instructions to disable or reduce fluid flow,thereby improving energy delivery to targeted tissue. Likewise, amedical device that requires more energy than the electronic controlunit to which it is connected can deliver might, for instance, perform acalibration check and disallow therapy delivery. In other words, insteadof the control unit rejecting or refusing to operate with a medicaldevice, which may be based on older algorithms established when thecontrol unit was manufactured, the medical device may refuse to workwith or otherwise reject operation with the control unit.

In another embodiment, the programming instructions associated with thecomputer readable memory of the medical device can, among other things,permanently alter another set of programming instructions resident inthe memory of the electronic control unit. If desired, the medicaldevice may be disposable, and/or may perform software maintenance and/orsoftware upgrades with respect to the electronic control unit.Value-added upgrades can be made in a visible manner (i.e., where auser/customer is cognizant that they are obtaining maintenance or anupgrade that may have been procured) or, if desired, in a substantiallyor even completely transparent manner with respect to a user.Consequently, to the extent desired, a “smart” medical device inaccordance with aspects of the invention can be configured to, at leastin part, serve as a means for providing a desired upgrade that can, asdesired, be distributed to intended targets within the device supplychain. As a further example, medical devices in accordance with theinvention may be used to improve localization of user interfaces. Thatis, many electronic control units are provided with multiple languagesoftware to assist with expanded, or even world-wide, distribution. Withsmart medical devices as taught herein, language data stored in thememory of the medical device can be specific to a location or targetedmarket or region. Such product specification may reduce the controlunit's (and the overall system's) associated memory requirements, andmay simplify access to new markets. Also, in cases where the medicaldevice provides an associated upgrade, the chance that a wrong orunintended version of an upgrade will be implemented with respect to aspecific electronic control unit, as compared to separate upgradesinvolving human-initiated upgrades, can be reduced.

In yet another embodiment, the programming instructions associated withthe computer readable memory of the medical device can, among otherthings, include instructions involving a user interface, asafety-monitoring feature, and/or a parameter associated with ablation.Additionally, the computer readable memory may include a set of datathat is downloadable from the memory upon connection of the electricalconnector with the electronic control unit. The data that isdownloadable can, for example, be used in connection with thecalibration of the electronically-controlled tool.

FIG. 4 comprises a flowchart generally illustrating a method ofproviding programming instructions to an electronic control unitaccording to an embodiment of the invention. At step 100 a medicaldevice is connected to an electronic control unit. In an embodiment, theelectronic control unit can recognize the presence of a script and runor process all or a portion of the script (as perhaps directed by thescript itself). At step 110, which occurs at some point afterconnection, a communication, or “handshaking,” is performed between themedical device and the electronic control unit, and software associatedwith the ECU determines if the computer readable memory of the medicaldevice includes programming instructions that are intended to bedelivered to the electronic control unit. If the answer is no, themethod continues with the running of the application, as generally notedat step 120. However, if instead it is determined that the medicaldevice includes programming instructions for delivery to the ECU, theinstructions are delivered to the ECU (e.g., step 130) as anintermediary step prior to the running of the application (step 120).

In connection with another embodiment of the invention, a system isdisclosed in which an electronic control unit is configured forconnection to a medical device and is further configured to transmit adata log from ECU memory (e.g., resident memory associated with the ECU)to memory (e.g., computer readable memory) associated with the connectedmedical device. The term “data log” is meant to be expansive withrespect to the reporting of faults or errors associated with the systemand may, among other things, include various forms and formats forreporting errors or faults, including various environmental and/orperformance or operational event-related data or information. In someembodiments of the invention, the format associated with the data logmay be specified or standardized. A system in accordance with such anembodiment may be configured so that a data log is transmitted upon orfollowing the occurrence or detection of a predetermined event.Additionally, it is noted that such an embodiment may be furthercombined or used in connection with aspects of one or more of thepreviously-disclosed embodiments, including those involving variousprogramming instructions.

As with previously-described embodiments of the invention, computerreadable memory associated with the medical device may be provided as asub-component within a tool or an electrical connector. Further, thepredetermined event may include a fault (e.g., a system error or fault)detected by the electronic control unit. Examples of faults may include,without limitation, one or more of the following: a power deliveryerror, a temperature error, a pressure error, a hardware malfunction, ora software malfunction. The predetermined event may further include auser input to the electronic control unit.

The ECU may detect a fault, including those faults currently detected byconventional systems, for example, low cooling pressure. Withconventional systems, the medical device is commonly returned to themanufacturer and the fault is typically reported to a quality technicianor engineer who will want to obtain relevant information, includingreal-time data, such as the temperatures that were reached duringoperation. In connection with the investigation, the logs from the ECUwill usually be requested and uploaded in some type of electronic formthat generally must be filtered to hopefully find records that identifythe cause of the fault or failure.

In contrast, the present invention may provide a device and relatedsystem in which the ECU may be configured, for example, to transmit orcopy the recorded log in real-time when a fault condition (e.g., lowpressure) is detected. Having the suspect medical device store relevantdata in its memory to a device that is being returned for inspection andanalysis before it is disconnected can provide an effective andconvenient way to transfer all or portions of the relevanttrouble-shooting information, which conventionally would need to beseparately downloaded and provided in some other media or form.Embodiments of the present invention can streamline such error or faultanalysis by providing the device and necessary and/or relevantinformation and data altogether and at the same time, without requiringa site visit to the control unit, which is commonly much bulkier and maynot need to be returned.

FIG. 5 comprises a flowchart generally depicting an exemplary method ofproviding data log information from a memory associated with a controlunit to a memory associated with a disconnectable medical deviceaccording to an embodiment of the invention. At step 200, a therapy isinitiated by the medical system. At some point, whether duringcalibration, initialization, or during activation, a fault is detectedby the system—typically by the electronic control unit (step 210). Theelectronic control unit then, which may substantially be in real-time,transmits a data log to the computer readable memory associated with theassociated medical device (step 220). Some time after the medical devicereceives and stores fault-related data (i.e., a data log) provided bythe control unit, the entire medical device, or the portion of thedevice including the memory, can be disconnected from the control unitand returned to the manufacturer, or other appropriate party (step 230).The data log stored in the memory of the medical device can then beanalyzed (step 240).

As further generally illustrated in FIG. 5, a method in accordance withthe present invention can, optionally, also involve a step (e.g., step250) of providing updated or corrected data or other programming to themedical device in question (if the device is capable of re-use) or toanother (typically similar) medical device for transmission of correcteddata or other programming (e.g., a script) to the associated controlunit or, in some cases, to another compatible control unit. As generallynoted in connection with step 260, an “updated” medical device can then,under appropriate conditions, be connected to the associated controlunit or to a compatible unit to provide updated or corrective data orinformation to the unit.

In yet a further embodiment of the invention, even if no problematicfault is detected by the system, a user may intentionally initiate orotherwise provide for a different form of predetermined event oroccurrence that is associated with the transfer all or portions ofselect or desired system data or information to the medical device. Thetransferred data and/or information, which may be stored in the computerreadable memory of the medical device, can later be used in connectionwith further data analysis of the system and/or the device. Suchinformation can be very useful for a variety of purposes. By way ofexample, without limitation, at times surgeons may make observationsduring a procedure, even to the extent of FDA reportable events, forwhich subsequent analysis may be required, and which would typicallyinvolve access and review of instrument data logs. Such user-initiated“recordings” may also help rule out certain contributing factors.Moreover, for pre-market clinical trial studies, study data could bereturned from a trial site to a study coordinator on a per-case basisusing systems and devices provided in accordance with aspects andembodiments of the invention. In yet a further exemplary embodiment, thesystem may be configured such that even if no fault is detected, the ECUmay transparently initiate, or a user may intentionally schedule, set upor initiate, or otherwise provide a pre-determined event or occurrencefor the transfer of data or other information to the medical device. Forinstance, the system may be configured to automatically provide aspecified type or form of data log to the medical device at a scheduledtime or following the conclusion of a treatment or therapy. Further,such transfers, may be substantially transparent to the user in thesense that the transfers may occur without requiring the user to takeaffirmative action or notice.

Although several embodiments of this invention have been described abovewith a certain degree of particularity, those skilled in the art couldmake numerous alterations to the disclose embodiments without departingfrom the spirit or scope of this invention. All directional references(e.g., upper, lower, upward, downward, left, right, leftward, rightward,top, bottom, above, below, vertical, horizontal, clockwise andcounterclockwise) are only use for identification purposes to aid thereader's understanding of the present invention, and do not createlimitations, particularly as to the position, orientation, or use of theinvention. Joinder references (e.g., attached, coupled, connected, andthe like) are to be construed broadly and may include intermediatemembers between a connection of elements and relative movement betweenelements. As such, joinder references do not necessarily infer that twoelements are directly connected and in fixed relation to each other. Itis intended that all matter contained in the above description or shownin the accompanying drawings shall be interpreted as illustrative onlyand not as limiting. Changes in detail or structure may be made withoutdeparting from the spirit of the invention as defined in the appendedclaims.

1. (canceled)
 2. A method of operating a medical device, comprising:providing a medical system including an electronic control unit having acomputer readable memory and a detachable medical device having acomputer readable memory including a set of operating instructions forthe medical device; connecting the detachable medical device to theelectronic control unit; copying the set of operating instructions forthe medical device from the computer readable memory of the medicaldevice into the computer readable memory of the electronic control unit;and delivering control signals from the electronic control unit to themedical device according to the operating instructions for the medicaldevice copied into the computer readable memory of the electroniccontrol unit.
 3. The method according to claim 2, further comprising:disconnecting the detachable medical device from the electronic controlunit; and installing a revised set of operating instructions for themedical device into the computer readable memory of the medical deviceafter disconnecting the detachable medical device from the control unit.4. The method according to claim 2, wherein the operating instructionsfor the medical device comprise at least one of instructions to operatethe medical device in an ablation mode and instructions to operate themedical device in a diagnostic mode.
 5. The method according to claim 2,further comprising transferring data from the electronic control unit tothe computer readable memory of the medical device while deliveringcontrol signals from the electronic control unit to the medical device.6. The method according to claim 5, wherein the data transferred fromthe electronic control unit to the compute readable memory of themedical device comprises data regarding at least one of a fault detectedby the medical system and an FDA reportable event detected by themedical system.
 7. The method according to claim 6, wherein the step oftransferring data from the electronic control unit to the computerreadable memory of the medical device is automatically initiated uponthe medical system detecting the at least one of the fault and the FDAreportable event.
 8. The method according to claim 5, wherein the stepof transferring data from the electronic control unit to the computerreadable memory of the medical device is user-initiated.
 9. A method ofoperating a medical system, the medical system including an electroniccontrol unit having a computer readable memory and a detachable medicaldevice having a computer readable memory including a set of operatinginstructions stored therein, the method comprising: copying the set ofoperating instructions from the computer readable memory of thedetachable medical device to the computer readable memory of theelectronic control unit upon connection of the detachable medical deviceto the electronic control unit; and delivering control signals from theelectronic control unit to the detachable medical device according tothe operating instructions copied to the computer readable memory of theelectronic control unit.
 10. The method according to claim 9, furthercomprising transferring data from the electronic control unit to thecomputer readable memory of the medical device while delivering controlsignals from the electronic control unit to the detachable medicaldevice.
 11. The method according to claim 10, wherein the datatransferred from the electronic control unit to the computer readablememory of the medical device comprises data regarding at least one of afault detected by the medical system and an FDA reportable eventdetected by the medical system.
 12. The method according to claim 11,wherein the step of transferring data from the electronic control unitto the computer readable memory of the medical device is automaticallyinitiated upon the medical system detecting the at least one of thefault and the FDA reportable event.
 13. The method according to claim10, wherein the step of transferring data from the electronic controlunit to the computer readable memory of the medical device isuser-initiated.
 14. The method according to claim 9, wherein the medicaldevice comprises an ablation catheter.
 15. The method according to claim9, wherein the operating instructions for the medical device comprise atleast one of instructions to operate the medical device in an ablationmode and instructions to operate the medical device in a diagnosticmode.
 16. A method of generating a data log in a medical systemincluding a detachable medical device, the method comprising: providinga medical system including an electronic control unit having a computerreadable memory and a detachable medical device having a computerreadable memory; with the detachable medical device connected to theelectronic control unit, delivering control signals from the electroniccontrol unit to the detachable medical device according to a set ofoperating instructions for the detachable medical device stored in thecomputer readable memory of the electronic control unit; andtransferring data from the electronic control unit to the computerreadable memory of the detachable medical device while deliveringcontrol signals from the electronic control unit to the detachablemedical device.
 17. The method according to claim 16, wherein the datatransferred from the electronic control unit to the computer readablememory of the detachable medical device comprises data regarding atleast one of a fault detected by the medical system and an FDAreportable event detected by the medical system.
 18. The methodaccording to claim 17, wherein the step of transferring data from theelectronic control unit to the computer readable memory of the medicaldevice is automatically initiated upon the medical system detecting theat least one of the fault and the FDA reportable event.
 19. The methodaccording to claim 16, wherein the step of transferring data from theelectronic control unit to the computer readable memory of the medicaldevice is user-initiated.
 20. The method according to claim 16, furthercomprising transferring the set of operating instructions for thedetachable medical device from the computer readable memory of thedetachable medical device to the computer readable memory of theelectronic control unit upon connection of the detachable medical deviceto the electronic control unit.